Drainage Catheter

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 Canyon Medical, Inc. Huiqi Jiang RA Manager Bldg. 3, Phase 2 Accelerator, #11 Yaogu Ave. Jiangbei New Area Nanjing, Jiangsu 210032 China Re: K254179 Trade/Device Name: Drainage Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: Class II Product Code: FGE, GBO Dated: August 18, 2026 Received: August 18, 2026 Dear Huiqi Jiang: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254179 - Huiqi Jiang Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K254179 - Huiqi Jiang Page 3 Sincerely, STEPHANIE COLE -S *for* Anthony Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254179 | ? | | Please provide the device trade name(s). | | ? | | Drainage Catheter | | | | Please provide your Indications for Use below. | | ? | | Drainage Catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K254179 - Page 1/8 CANYON 510(k) Summary ### 1. 510(k) Owner Canyon Medical Inc. ### 2. Submission Correspondent Submitter Name: Canyon Medical Inc. Address: Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area, 210032, Nanjing, Jiangsu Province, People's Republic of China Official Correspondent: Ms. Huiqi Jiang Position: RA Manager E-mail: jhq@canyonmedical.com.cn Telephone: +86-13241196637 ### 3. Date of Preparation: September 17, 2026 ### 4. Subject Device Information | Common Name: | Drainage Catheter | | --- | --- | | Trade Name: | Drainage Catheter | | Regulation Number: | 21 CFR 876.5010 | | Regulation Name: | Biliary catheter and accessories | | Device Class: | II | | Product Codes: | FGE, GBO | ### 5. Predicate Devices Information | Subject device | Predicate device | | --- | --- | | Drainage Catheter (Seldinger Type) | K210419 BIOTEQ Drainage Catheter BT-PDS-series | | Drainage Catheter (Single Step Type) | K200103 BIOTEQ Drainage Catheter Set (One Step Type) | ### 6. Device Description The subject device, Drainage Catheter, is a percutaneous drainage catheter with hydrophilic coating and is used for drainage of abscess and fluid collections. Based on the application method, the Drainage Catheter is classified by puncture technique into Single Step Drainage Catheter and Seldinger Drainage Catheter. Both catheters are made from a soft, biocompatible plastic, a material that is radiopaque. The operator can use different Drainage Catheters according to the type of accumulated fluid and place of accumulation. These sets include catheter sizes 5 Fr-16 Fr, pertaining to various fluid 2 {5} K254179 - Page 2/8 [LOGO] 510(k) Summary viscosity and according to the position of the accumulation. ### 7. Indications for Use Drainage Catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and other fluids. ### 8. Summary and Comparison of Technological Characteristics Drainage Catheter is described by puncture technique as the Single Step Drainage Catheter and Seldinger Drainage Catheter. Two predicate devices were selected for comparison. Equivalence comparison is identified with following summary of technical characteristics: 3 {6} K254179 - Page 3/8 CANTON 510(k) Summary Table 1. Comparison of Single Step Drainage Catheter to the predicate device | Item | Subject Device | Predicate Device | Substantial equivalence determination | | --- | --- | --- | --- | | Proprietary Name | Drainage Catheter | BIOTEQ Drainage Catheter Set (One Step Type) | | | 510(k) No. | K254179 | K200103 | | | Classification | Class II | Class II | Same | | Product Code | FGE, GBO | FGE, GBO | Same | | Regulation Number | 21 CFR 876.5010 | 21 CFR 876.5010 | Same | | Indications for Use | Drainage Catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and other fluids. | Same | | Type of Use | Prescription Use | Prescription Use | Same | | Intended User | Adults | Adults and recommending clinicians should choose an appropriate catheter size for pediatric use. | Equivalent The intended user of the subject device is covered by the predicate device. | | Catheter Shaft Material | TPU | TPU | Same | | Distal Configuration | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | Same | | Distal Shape | Pigtail, Close-loop Pigtail, Mini-Pigtail, Mini-Close loop Pigtail | Pigtail, Closed-Pigtail, Mini-Pigtail, Mini-closed Pigtail, J shape | Equivalent Except J shape, both devices have various pigtail and closed shape; only the names for closed shapes are different. The distal shape of the subject device is covered by the predicate device. | | Distal Hydrophilic Coating | Yes | Yes | Same | | Shaft Depth Printing | Yes | Yes | Same | 4 {7} K254179 - Page 4/8 CANTON 510(k) Summary | Item | | Subject Device | Predicate Device | Substantial equivalence determination | | --- | --- | --- | --- | --- | | Proprietary Name | | Drainage Catheter | BIOTEQ Drainage Catheter Set (One Step Type) | | | 510(k) No. | | K254179 | K200103 | | | Proximal Hub Assembly | | Hub (for String Lock Pigtail) | Hub (for String Lock Pigtail), F.L.L. Adapter | Same The proximal hub assembly of subject device is hub (the hub itself includes the adapter). Both devices have hub and adapter. | | Size | Non-String Lock | Pigtail, Close-loop Pigtail: 5, 6, 7, 8, 10, 12, 14, 16 Fr | 5, 6, 7, 8, 10, 12, 14, 16 Fr | Equivalent | | | String Lock | Pigtail, Close-loop Pigtail: 5, 6, 7, 8, 10, 12, 14, 16 Fr Mini-Pigtail, Mini-Close loop Pigtail: 6, 7, 8, 10, 12, 14 Fr | 6, 7, 8, 10, 12, 14, 16 Fr | Equivalent | | Usable Length | | Pigtail, Close-loop Pigtail: 200, 250, 300, 350, 400, 450, 500 mm Mini-Pigtail, Mini-Close loop Pigtail: 200, 250, 300 mm | 200, 250, 300, 350, 400, 450, 500 mm | Equivalent | | Included Insert Accessory | | • Stiffening Cannula • Trocar Stylet • Flexible Stiffening Cannula • Hub Clip (for String Lock Pigtail) • Thread (for String Lock Pigtail) • Split Straightener • Radiopaque band | • Trocar Needle (Metal Stiffening Cannula) • Trocar Stylet • Flexible (plastic) Stiffening Cannula • Wire cap (for string Lock Pigtail) • Suture Wire • Curve Straightener • Radiopaque band | Equivalent The accessories of subject device are same as the predicate device, only the descriptive names are different. | | Packaging | | Tyvek/(PET/LDPE) pouch | Tyvek/(PET/LDPE) pouch | Same | | Sterilization Method | | Ethylene Oxide | Ethylene Oxide | Same | 5 {8} K254179 - Page 5/8 CAN'ON 510(k) Summary Table 2. Comparison of Seldinger Drainage Catheter to the predicate device. | Item | Subject Device | Predicate Device | Substantial equivalence determination | | --- | --- | --- | --- | | Proprietary Name | Drainage Catheter | BIOTEQ Drainage Catheter Set (Seldinger Type) | | | 510(k) No. | K254179 | K210419 | | | Classification | Class II | Class II | Same | | Product Code | FGE, GBO | FGE, GBO | Same | | Regulation Number | 21 CFR 876.5010 | 21 CFR 876.5010 | Same | | Indications for Use | Drainage Catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | Same | | Type of Use | Prescription Use | Prescription Use | Same | | Intended User | Adults | Adults and recommending clinicians should choose an appropriate catheter size for pediatric use. | Equivalent The intended user of the subject device is covered by the predicate device. | | Catheter Shaft Material | TPU | TPU | Same | | Distal Configuration | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | Same | | Distal Shape | Pigtail, Mini-Pigtail, Close-loop Pigtail, Mini-Close loop Pigtail, Multi-Side holes Pigtail | Pigtail, Closed-Pigtail | Equivalent Both devices have pigtail and closed shapes. The subject device includes a multi-side holes pigtail configuration. | | Distal Hydrophilic Coating | Yes | Yes | Same | | Shaft Depth Printing | Yes | Yes | Same | 6 {9} K254179 - Page 6/8 CAN'ON 510(k) Summary | Item | | Subject Device | Predicate Device | Substantial equivalence determination | | --- | --- | --- | --- | --- | | Proprietary Name | | Drainage Catheter | BIOTEQ Drainage Catheter Set (Seldinger Type) | | | 510(k) No. | | K254179 | K210419 | | | Proximal Hub Assembly | | Hub (for String Lock Pigtail) | Hub (for String Lock Pigtail), F.L.L. Adapter | Same The proximal hub assembly of subject device is hub (the hub itself includes the adapter). Both devices have hub and adapter. | | Size | Non-String Lock | Pigtail, Close-loop Pigtail: 5, 6, 7, 8, 10, 12, 14, 16 Fr Multi-Side holes Pigtail: 8, 10, 12, 14 Fr | 8, 10, 12, 14 Fr | Equivalent | | | String Lock | Pigtail, Close-loop Pigtail: 5, 6, 7, 8, 10, 12, 14, 16 Fr Mini-Pigtail, Mini-Close loop Pigtail: 6, 7, 8, 10, 12, 14 Fr Multi-Side holes Pigtail: 8, 10, 12, 14 Fr | | | | Usable Length | | Pigtail, Close-loop Pigtail: 200, 250, 300, 350, 400, 450, 500 mm Mini-Pigtail, Mini-Close loop Pigtail: 200, 250, 300 mm Multi-Side holes Pigtail: 400 mm | 400, 450, 500 mm | Equivalent | | Included Insert Accessory | | • Stiffening Cannula • Flexible Stiffening Cannula • Hub Clip (for String Lock Pigtail) • Thread (for String Lock Pigtail) • Split Straightener • Radiopaque band | • Metal Stiffening Cannula • Flexible (plastic) Stiffening Cannula • Wire cap • Suture Wire • Curve Straightener • Radiopaque band | Equivalent The accessories of subject device are same as the predicate device, only the descriptive names are different. | | Packaging | | Tyvek/(PET/LDPE) pouch | Tyvek/(PET/LDPE) pouch | Same | | Sterilization | | Ethylene Oxide | Ethylene Oxide | Same | 7 {10} K254179 - Page 7/8 CANTON 510(k) Summary The technological characteristics of the subject device are substantially equivalent to those of predicate devices. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following: - Same indications for use - Same fundamental technology - Same sterilization method ### 9. Non-Clinical Test Summary The subject device has been subjected to compliance testing according to ISO 11135, ISO 11607-1, ISO 11607-2, ASTM F1980-21, ASTM F640-23, ASTM F1828, EN 1617, ISO 20697, and ISO 80369. Results from the testing confirm the design requirements. 1) Biocompatibility The subject device is an externally communicating medical device with tissue contact of more than 30 days. Relevant tests are conducted as per ISO 10993 series standards. 2) Package Validation The primary package of the proposed device is intended to maintain the sterility of the product during its shelf life. 3) Transport The subject device is processed by compression, first vibration, shock and second vibration, and then tested for packaging integrity during transport. 4) Shelf Life Accelerated aging was used to simulate storage of 3 years and the test results demonstrate that the aged samples complied with the pre-determined acceptance criteria. 5) EO/ECH Residual Examination of the EO and ECH residuals was conducted in accordance with ISO 10993-7 to evaluate whether the sterilized proposed device comply with allowable limits for permanent patient contact (>30 days). 8 {11} K254179 - Page 8/8 CANTON 510(k) Summary # 6) Performance The performance testing was conducted in accordance with EN 1617, ISO 20697, ASTM F640, ISO 80369-7 and ASTM F1828. All test results demonstrated that the Drainage Catheter met the requirements of the pre-defined acceptance criteria and intended use. # 10. Clinical Test None. # 11. Conclusion The testing demonstrates that the subject device is safe and effective, performs as well as the legally-marketed predicate devices and raises no new questions of safety or effectiveness. 9